TN Visa Validation Engineer Jobs
Validation Engineer roles qualify for TN visa sponsorship under the USMCA treaty through the Engineer category, which covers quality systems, process validation, and IQ/OQ/PQ work. Canadian citizens can apply at the port of entry the same day an offer is made. Mexican citizens obtain a TN visa through a U.S. consular appointment.
Find TN Visa Validation Engineer JobsOverview
Showing 5 of 318+ Validation Engineer jobs
See all 318+ Validation Engineer Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new Validation Engineer roles.
Get Access To All JobsDate: Sep 9, 2026
Location: Somerset, NJ, US
Company: Lupin
Job Description
- Ensure compliance with regulatory requirements including 21 CFR Part 11, Electronic Records and Electronic Signatures, and applicable predicate rules, aligned with CSA (Computer Software Assurance) and GAMP 5 principles.
- Support validation activities in GMP laboratory and manufacturing systems, including system implementation, upgrades, and remediation.
- Work on networked and standalone systems, including PLC/firmware-based computerized systems.
-
Implement and assess IT and Data Integrity controls, including:
-
User access management
-
Audit trail configuration and review
-
Data protection and integrity controls
-
Backup, restore, and disaster recovery processes
-
Author and review validation lifecycle documentation, including:
-
User Requirements Specification (URS)
-
Functional Requirements Specification (FRS)
-
System Configuration/Design Specifications
-
Prepare, execute, and document validation protocols, including:
-
IQ, OQ, PQ, and UAT
-
Requirements Traceability Matrix (RTM)
-
Discrepancy reports and validation summary reports
-
Collaborate with business stakeholders to gather requirements and ensure timely reviews and approvals of validation documentation.
- Support and manage activities within quality systems such as TrackWise Digital, Veeva, and prior experience in using electronic systems is mandatory.
- Execute system upgrades (including SaaS systems), PLC/SCADA/Firmware-based systems and perform validation activities to maintain systems in a validated state.
- Act as a System Administrator for GxP systems, including configuration and troubleshooting whenever required.
- Coordinate with cross-functional teams (QA, IT, Engineering, QC, Production) and external vendors to ensure successful project execution.
- Deliver multiple projects independently within defined timelines, ensuring compliance with internal SOPs and GMP standards.
- Conduct CSV remediations, gap assessments, risk assessments, and periodic reviews.
Qualification and Experience
- MS/BA Degree in Computer Science, IT, Engineering, Science, or Business
- Bachelor’s degree in engineering, Computer Science, or a related technical discipline.
- Strong knowledge of CSV lifecycle, GAMP 5, and 21 CFR Part 11 compliance requirements.
- Demonstrated experience in GMP-regulated environments (pharmaceutical or biotech).
- Hands-on experience with validation documentation and protocol execution (IQ/OQ/PQ/UAT).
- Strong understanding of data integrity principles and IT controls in GxP systems.
- Experience with enterprise and laboratory systems, including networked and standalone systems.
- Familiarity with QMS/DMS platforms such as TrackWise Digital, Veeva Vault, or MasterControl.
- Experience supporting system upgrades and SaaS validation activities.
- Strong communication and stakeholder engagement skills.
- Prior experience as a System Administrator in GxP-regulated systems is preferred.
The physical requirements of the position generally include: standing, walking, sitting, using hands and fingers, reaching with hands and arms, talking and hearing. In some circumstances, bending, kneeling, crouching, stooping, and crawling may apply. This position may require lifting up to 35 pounds occasionally. Generally work is performed in a combination of a corporate and manufacturing environment.
Lupin is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, gender, religion, age, disability, veteran’s status, or any other classification as required by applicable law.
This is an exciting opportunity for a quality-driven leader passionate about advancing patient-centric drug-device combination products and ensuring the highest standards of compliance and operational excellence.
Compensation
- The anticipated salary range for this position in New Jersey is $90,000 - $110,000.00, plus discretionary performance bonus (based upon eligibility). The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Lupin is a multi-state employer, and this salary range may not reflect positions that work in other states.
Physical Requirements
The physical requirements of the position generally include: standing, walking, sitting, using hands and fingers, reaching with hands and arms, talking and hearing. In some circumstances, bending, kneeling, crouching, stooping, and crawling may apply. This position may require lifting up to 15 pounds occasionally. Generally work is performed in an office environment.
Competencies
- Collaboration
- Customer Centricity
- Developing Talent
- Innovation & Creativity
- Process Excellence
- Result Orientation
- Stakeholder Management
- Strategic Agility
Nearest Major Market: New Jersey
Date: Sep 9, 2026
Location: Somerset, NJ, US
Company: Lupin
Job Description
- Ensure compliance with regulatory requirements including 21 CFR Part 11, Electronic Records and Electronic Signatures, and applicable predicate rules, aligned with CSA (Computer Software Assurance) and GAMP 5 principles.
- Support validation activities in GMP laboratory and manufacturing systems, including system implementation, upgrades, and remediation.
- Work on networked and standalone systems, including PLC/firmware-based computerized systems.
-
Implement and assess IT and Data Integrity controls, including:
-
User access management
-
Audit trail configuration and review
-
Data protection and integrity controls
-
Backup, restore, and disaster recovery processes
-
Author and review validation lifecycle documentation, including:
-
User Requirements Specification (URS)
-
Functional Requirements Specification (FRS)
-
System Configuration/Design Specifications
-
Prepare, execute, and document validation protocols, including:
-
IQ, OQ, PQ, and UAT
-
Requirements Traceability Matrix (RTM)
-
Discrepancy reports and validation summary reports
-
Collaborate with business stakeholders to gather requirements and ensure timely reviews and approvals of validation documentation.
- Support and manage activities within quality systems such as TrackWise Digital, Veeva, and prior experience in using electronic systems is mandatory.
- Execute system upgrades (including SaaS systems), PLC/SCADA/Firmware-based systems and perform validation activities to maintain systems in a validated state.
- Act as a System Administrator for GxP systems, including configuration and troubleshooting whenever required.
- Coordinate with cross-functional teams (QA, IT, Engineering, QC, Production) and external vendors to ensure successful project execution.
- Deliver multiple projects independently within defined timelines, ensuring compliance with internal SOPs and GMP standards.
- Conduct CSV remediations, gap assessments, risk assessments, and periodic reviews.
Qualification and Experience
- MS/BA Degree in Computer Science, IT, Engineering, Science, or Business
- Bachelor’s degree in engineering, Computer Science, or a related technical discipline.
- Strong knowledge of CSV lifecycle, GAMP 5, and 21 CFR Part 11 compliance requirements.
- Demonstrated experience in GMP-regulated environments (pharmaceutical or biotech).
- Hands-on experience with validation documentation and protocol execution (IQ/OQ/PQ/UAT).
- Strong understanding of data integrity principles and IT controls in GxP systems.
- Experience with enterprise and laboratory systems, including networked and standalone systems.
- Familiarity with QMS/DMS platforms such as TrackWise Digital, Veeva Vault, or MasterControl.
- Experience supporting system upgrades and SaaS validation activities.
- Strong communication and stakeholder engagement skills.
- Prior experience as a System Administrator in GxP-regulated systems is preferred.
The physical requirements of the position generally include: standing, walking, sitting, using hands and fingers, reaching with hands and arms, talking and hearing. In some circumstances, bending, kneeling, crouching, stooping, and crawling may apply. This position may require lifting up to 35 pounds occasionally. Generally work is performed in a combination of a corporate and manufacturing environment.
Lupin is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, gender, religion, age, disability, veteran’s status, or any other classification as required by applicable law.
This is an exciting opportunity for a quality-driven leader passionate about advancing patient-centric drug-device combination products and ensuring the highest standards of compliance and operational excellence.
Compensation
- The anticipated salary range for this position in New Jersey is $90,000 - $110,000.00, plus discretionary performance bonus (based upon eligibility). The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Lupin is a multi-state employer, and this salary range may not reflect positions that work in other states.
Physical Requirements
The physical requirements of the position generally include: standing, walking, sitting, using hands and fingers, reaching with hands and arms, talking and hearing. In some circumstances, bending, kneeling, crouching, stooping, and crawling may apply. This position may require lifting up to 15 pounds occasionally. Generally work is performed in an office environment.
Competencies
- Collaboration
- Customer Centricity
- Developing Talent
- Innovation & Creativity
- Process Excellence
- Result Orientation
- Stakeholder Management
- Strategic Agility
Nearest Major Market: New Jersey
See all 318+ TN Visa Validation Engineer Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new TN Visa Validation Engineer Jobs.
Get Access To All JobsTips for Finding TN Visa Sponsorship as a Validation Engineer
Frame your credentials around U.S. engineering standards
TN visa approval hinges on demonstrating a direct match between your degree field and the Validation Engineer role. If your degree says 'Industrial Engineering' or 'Biomedical Engineering,' make sure your credential evaluation explicitly maps it to the duties in your offer letter.
Target regulated industries with established TN pipelines
Pharmaceutical, medical device, and semiconductor manufacturers file TN petitions for Validation Engineers regularly because FDA compliance mandates the role. Employers in these industries already understand IQ/OQ/PQ language in offer letters, which reduces back-and-forth before you get a sponsorship commitment.
Search for Validation Engineer roles using Migrate Mate
Migrate Mate filters jobs by TN visa sponsorship availability so you're not sorting through postings that won't support your status. Use it to identify employers already familiar with the Engineer category under USMCA before you apply.
Get your offer letter reviewed before crossing the border
Canadians can secure TN status at a U.S. port of entry the same day, but CBP officers can deny entry if your offer letter is vague about job duties or degree requirements. The letter must describe a role that unambiguously falls under the Engineer occupational category.
Distinguish validation from quality assurance in your documents
CBP and consular officers sometimes conflate Validation Engineers with QA technicians, who do not qualify for TN status. Your resume, offer letter, and any supporting documentation should consistently use engineering-specific language: protocol development, design qualification, risk-based validation, GAMP 5.
Prepare for Mexican nationals to navigate consular scheduling early
Mexican citizens must obtain TN status at a U.S. consulate, not at a port of entry. Appointment availability at Ciudad Juarez and Monterrey can lag several weeks, so start the scheduling process as soon as you have a signed offer letter and USCIS-ready documentation.
Validation Engineer TN Visa: Frequently Asked Questions
Does a Validation Engineer role qualify for TN visa status?
Yes, Validation Engineers qualify under the USMCA Engineer occupational category, which covers professionals who apply engineering principles to design, qualification, and process validation work. Your offer letter must describe duties consistent with engineering-level responsibilities. Roles framed primarily as technician or QA inspector work typically do not qualify, so the language in your job offer matters significantly.
How does the TN visa compare to H-1B for Validation Engineer jobs?
The TN visa has no annual lottery, no cap for Canadian citizens, and no lengthy USCIS petition wait for Canadians who apply at a port of entry. H-1B visa requires employer sponsorship, a lottery selection, and months of processing. For Validation Engineers with a qualifying degree and a U.S. job offer, TN is typically faster and more predictable than pursuing H-1B.
What documentation does a Validation Engineer need for TN status?
You need a detailed offer letter from a U.S. employer describing your engineering duties, your academic credential (a bachelor's degree or higher in an engineering field), and proof of Canadian or Mexican citizenship. If your degree is from a non-U.S. institution, a credential evaluation confirming U.S. equivalency strengthens your application and reduces the risk of a CBP denial.
Where can I find Validation Engineer jobs that offer TN visa sponsorship?
Migrate Mate is built specifically for Canadian and Mexican professionals seeking roles with TN visa sponsorship. It surfaces Validation Engineer positions at employers already familiar with the USMCA Engineer category, so you can focus your search on companies prepared to support your TN application rather than starting the conversation from scratch.
Can a Validation Engineer on TN status change employers without losing status?
Yes, but your TN authorization is tied to the specific employer named in your approval. You must obtain new TN documentation before starting work with a new employer. Canadians can do this at a port of entry with a new offer letter. Mexican citizens need a new consular appointment. There is no grace period that allows you to start the new job while documentation is pending.